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临床试验/CTIS2024-511053-22-00
CTIS2024-511053-22-00招募中1 期

PiSCATIN - Simvastatin for the treatment of primary sclerosing cholangitis (PSC) - a randomized double-blind, placebo-controlled multicenter study

Karolinska University Hospital0 个研究点目标入组 560 人开始时间: 2024年2月13日最近更新:

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
560

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • Patients with a cholangiographically verified PSC and/or liverbiopsy with and without IBD (patients with a present autoimmun hepatit and small duct PSC can be included), Men and women =18 years but =75 years, Patient has given written consent to participate in the study, MR/MRCP within 4 months, Coloscopy within 24 months if the patient has a known IBD, Female of childbearing potential must agree to use a highly efficient method of contraception during the study participation.

排除标准

  • Patients on waiting list for transplantation, Transplanted patients, Patients with severe liver failure = Child B 9 points, Previous varices bleeding secondary to end stage liver disease, Previous cholangiocarcinoma, Patients with secondary sclerosing cholangitis, Patients who have been taking any statin medication during the last 3 months, Intolerance to statins, Pregnancy and breastfeeding

研究者

发起方
Karolinska University Hospital

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